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Femasys CEO and Founder Kathy Lee-Sepsick Meets with the White House’s Office of Science and Technology Policy to Discuss the Cancer Moonshot Initiative

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Femasys announced that CEO Kathy Lee-Sepsick met with the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot initiative and the company's diagnostic tool, FemCerv. FemCerv is designed for the detection of cervical cancer, allowing for the collection of an uncontaminated sample virtually pain-free. Femasys aims to expand its cancer diagnostic tools to include an endometrial sampler for uterine cancer. Additionally, the company will showcase its products at the 2024 ACOG Annual Clinical and Scientific Meeting in San Francisco from May 17-19.

Positive
  • Meeting with White House OSTP could enhance visibility and credibility for Femasys.
  • FemCerv product aligns with Cancer Moonshot's focus on early detection of cancer.
  • Potential future product developments, like an endometrial sampler for uterine cancer, could expand market reach.
  • Participation in 2024 ACOG Annual Clinical and Scientific Meeting provides exposure to key industry professionals.
  • Current portfolio includes four commercially available products, indicating a diversified revenue stream.
Negative
  • No immediate financial gains or partnerships announced from the OSTP meeting.
  • Future product developments, such as the endometrial sampler, are still speculative and may face regulatory hurdles.
  • Marketing and R&D expenses for new products may increase financial strain.
  • Uncertainty regarding the commercialization success of FemBloc, which is still in late-stage clinical development.

Lee-Sepsick Discussed Company’s FemCerv® Endocervical Tissue Sampler and its Role in Cervical Cancer Diagnosis

ATLANTA, May 17, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces CEO and Founder Kathy Lee-Sepsick has met with staff from the White House Office of Science and Technology Policy (OSTP) to discuss the President and First Lady’s Cancer Moonshot and the Company’s FemCerv® product. According to The White House, OSTP “works to bring that idea to life by harnessing the power of science, technology, and innovation to achieve America’s great aspirations.” OSTP also supports the Cancer Moonshot, which is focused on mobilizing a national effort to end cancer.

During the meeting, Ms. Lee-Sepsick and the OSTP staff discussed the priority actions for the Cancer Moonshot, including  important priorities related to cervical cancer. This discussion gave Ms. Lee-Sepsick the opportunity to raise awareness of FemCerv, Femasys’ diagnostic tool for the detection of cervical cancer, with a purposeful design that allows for the collection of a complete and uncontaminated sample in a virtually pain-free procedure. Femasys intends to broaden its cancer diagnostic portfolio with an endometrial sampler for uterine cancer in the future.

“Meeting with the esteemed Office of Science and Technology Policy was a remarkable experience, where I had the opportunity to discuss our work in cancer diagnosis with our FemCerv product for cervical cancer and other products in development,” stated Ms. Lee-Sepsick. “The Cancer Moonshot emphasizes the importance of early detection, and we are excited to explore avenues to collaborate, as we commercialize our diagnostic product that is in line with the Cancer Moonshot’s mission to dramatically reduce cervical cancer.”

Femasys is an Atlanta-based company that provides minimally invasive women’s reproductive health solutions, which are manufactured in the U.S. Later this week, the Company will be displaying its four commercially available products: FemaSeed® – FDA-cleared, intratubal insemination; FemVue® – contrast-generating device; FemCath® – selective delivery catheter; FemCerv® – endocervical tissue sampler; and its current lead product candidate in late-stage clinical development FemBloc® – a non-surgical, non-hormonal permanent birth control, at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The event is taking place in San Francisco’s Moscone Center May 17-19, 2024 and Femasys will be exhibiting at Booth #1413.

About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on XFacebook and LinkedIn.

Forward-Looking Statements 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. 

Contacts: 
Investors: 
Gene Mannheimer
IR@femasys.com

Media Contact: 
Kati Waldenburg
Media@femasys.com


FAQ

What did Femasys discuss with the White House Office of Science and Technology Policy?

Femasys discussed the Cancer Moonshot initiative and their FemCerv diagnostic tool for cervical cancer detection.

When did Femasys CEO meet with the White House OSTP?

The meeting took place on May 17, 2024.

What is the FemCerv product by Femasys?

FemCerv is an endocervical tissue sampler designed for the detection of cervical cancer, allowing for the collection of an uncontaminated sample in a virtually pain-free procedure.

Will Femasys introduce new cancer diagnostic products?

Yes, Femasys plans to develop an endometrial sampler for uterine cancer.

What event will Femasys attend to showcase their products?

Femasys will attend the 2024 ACOG Annual Clinical and Scientific Meeting from May 17-19 in San Francisco.

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